This trial is active, not recruiting.

Condition cholecystitis
Treatments injection of indocyanine green (icg), near infrared cholangiography fluorescence (nirf-c)
Phase phase 1
Sponsor Ohio State University
Collaborator Stryker Instruments
Start date January 2013
End date April 2014
Trial size 102 participants
Trial identifier NCT02070640, 2011H0239


The purpose of this study is to evaluate an imaging system using Indocyanine Green (ICG) to assist in real-time identification of anatomy during cholecystectomy (gallbladder removal). We propose to define the effectiveness of NIRF-C in identifying the cystic duct junction during cholecystectomy. Also, the knowledge gained from this study will be used in the development of a novel microbubble/ICG compound, which will serve as a dual mode, ultrasound/fluorescence imaging system for abdominal surgery.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.
injection of indocyanine green (icg)
2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.
near infrared cholangiography fluorescence (nirf-c) Stryker 1488 Camera System
These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce.

Primary Outcomes

Complications related to ICG
time frame: From time of injection to 1st post-op follow-up

Secondary Outcomes

Incidence of anatomic identification with NIRF-C
time frame: Intraoperative
time frame: Intraoperative

Eligibility Criteria

Male or female participants from 18 years up to 89 years old.

Inclusion Criteria: - Age 18-89 - Planned laparoscopic cholecystectomy Exclusion Criteria: - Inability to provide informed consent - Pregnant - Allergy to ICG, iodine, and/or shellfish - Acute cholecystitis, cholangitis, and/or cirrhosis (main study) - Lactating

Additional Information

Official title Near Infrared Fluorescence Cholangiography During Cholecystectomy
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Ohio State University.